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Post by itellthefuture777 on Jun 11, 2021 9:03:15 GMT -5
Honestly who cares and why should it matter? We have access and rights if we choose to a promising NCE for pulmonary diseases. That’s what matters. Some of you make a spectacle out of everything. It’s laughable. We have a NCE in development now, that is ALL that matters with this deal. If your husband or wife came home with a new car wouldn't you want to know what it cost? Mnkd has a quarter billion in cash...if my wife had that she could drive home in a Rolls and I wouldn't ask..
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Post by uvula on Jun 11, 2021 9:08:06 GMT -5
If your wife had that much money she could fund a clinical study to prove the superiority of afrezza, a drug that already exists.
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Post by mango on Jun 11, 2021 9:27:38 GMT -5
Honestly who cares and why should it matter? We have access and rights if we choose to a promising NCE for pulmonary diseases. That’s what matters. Some of you make a spectacle out of everything. It’s laughable. We have a NCE in development now, that is ALL that matters with this deal. If your husband or wife came home with a new car wouldn't you want to know what it cost? I doubt we spent very much on this. If you’re very concerned about it like awesomo is then perhaps one of ya’ll can contact MannKind IR and express your concerns and frustrations there. Report back with your findings.
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Post by cretin11 on Jun 11, 2021 9:34:26 GMT -5
MNKD share price action since this arrangement was announced is probably a good indicator of how big a deal this is.
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Post by mnkdfann on Jun 11, 2021 9:54:22 GMT -5
You see that big fat “If” in bullet point two? The entire agreement rests on that. So again, a “partnership” with nothing concrete, no financial details, just “we’re maybe gonna do something in a few years, but probably not”. This doesn’t even look like an actual company especially given that you can barely find any info on them and they “share” a suite with like 4+ other completely random entities. I’ll bet you good money mango that’s nothing comes of this. You’re so confident, put your money where your mouth is. I'm sympathetic with your point of view, but maybe we can take solace in that this time Mannkind only entered into a collaboration agreement and did a convertible promissory note purchase agreement to support Thirona’s Series A financing, rather than just buy the entire company outright (like it did with QrumPharma)?
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Post by awesomo on Jun 11, 2021 9:59:18 GMT -5
You see that big fat “If” in bullet point two? The entire agreement rests on that. So again, a “partnership” with nothing concrete, no financial details, just “we’re maybe gonna do something in a few years, but probably not”. This doesn’t even look like an actual company especially given that you can barely find any info on them and they “share” a suite with like 4+ other completely random entities. I’ll bet you good money mango that’s nothing comes of this. You’re so confident, put your money where your mouth is. I'm sympathetic with your point of view, but maybe we can take solace in that this time Mannkind only entered into a collaboration agreement and did a convertible promissory note purchase agreement to support Thirona’s Series A financing, rather than just buy the entire company outright (like it did with QrumPharma)? What would they even buy? A cubicle in the lawyer's office?
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Post by mango on Jun 11, 2021 10:03:24 GMT -5
If your wife had that much money she could fund a clinical study to prove the superiority of afrezza, a drug that already exists. I do not ever see us doing a superiority clinical trial with Afrezza, however, we have already demonstrated superiority in the Affinity clinical trials and again in the STAT clinical trial. The inherent advantages of Afrezza over other prandial insulins and also non-insulin anti-glycemic agents are painfully obvious. I am puzzled about the outcome of the Affinity 2 trial. I thought I remembered you saying earlier that you needed a 0.5% change in HbA1c to show superiority, yet you only showed 0.4%. Was the trial successful?• Yes. The study met its primary endpoint of superiority at a highly significant level, with a P value of <0.0001. Demonstrating superiority is what was required in the study and that is what we showed. The FDA did not specify a particular margin that would be needed to show superiority. Instead, the success of such a trial is generally governed by the statistics. • Biostatisticians design studies around assumed levels of variability and needed confidence intervals to assess how large the study must be. To do this, they come up with powering assumptions designed to show a particular level of change with an assumed confidence interval. In our case, the Affinity 2 study was originally designed to show a 0.5% reduction with a one-sided alpha of 0.025%, with a high degree of confidence. The actual difference turned out to be 0.4%, with a remarkable P value of 0.0001, demonstrating extreme significance. • It is clear that in Affinity 2 we demonstrated the superiority of Afrezza in an unequivocal fashion. www.sec.gov/Archives/edgar/data/899460/000119312513346807/d589871dex991.htm
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Post by mnkdfann on Jun 11, 2021 13:15:37 GMT -5
About Thirona Bio Thirona Bio is focused on the development of drugs for fibrotic diseases. Target indications include scleroderma, keloid scars and certain cancers where there are no effective therapies. The Company’s unique approach uses a potent, topically applied drug to inhibit TGF-β “locally”, thereby minimizing the potential risk of systemic exposure. The Company is headquartered in San Diego, California. More information can be found at www.thirona.bio.com. LFD latched onto this point in a comment at SA. seekingalpha.com/article/4430462-mannkind-new-direction-abandoning-technosphere-dpi-platform#comment-891946722LDR: Mannkind wants to convert the Thirona compound (one Thirona promotes for topical risk specifically to avoid systemic exposure) into a dry powder and dose it directly into lungs where it will immediately be put directly into a human’s systemic system and spread to every part of their body other than the eye corneas.Don't shoot the messenger I'm just relaying what I saw at SA. If someone wants rebut (correct?) LFD, the link is above.
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Post by longliner on Jun 11, 2021 13:29:37 GMT -5
About Thirona Bio Thirona Bio is focused on the development of drugs for fibrotic diseases. Target indications include scleroderma, keloid scars and certain cancers where there are no effective therapies. The Company’s unique approach uses a potent, topically applied drug to inhibit TGF-β “locally”, thereby minimizing the potential risk of systemic exposure. The Company is headquartered in San Diego, California. More information can be found at www.thirona.bio.com. LFD latched onto this point in a comment at SA. seekingalpha.com/article/4430462-mannkind-new-direction-abandoning-technosphere-dpi-platform#comment-891946722LDR: Mannkind wants to convert the Thirona compound (one Thirona promotes for topical risk specifically to avoid systemic exposure) into a dry powder and dose it directly into lungs where it will immediately be put directly into a human’s systemic system and spread to every part of their body other than the eye corneas.Don't shoot the messenger I'm just relaying what I saw at SA. If someone wants rebut (correct?) LFD, the link is above. The horrors...the horrors....... Run, while you still can...
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Post by mango on Jun 11, 2021 13:31:49 GMT -5
About Thirona Bio Thirona Bio is focused on the development of drugs for fibrotic diseases. Target indications include scleroderma, keloid scars and certain cancers where there are no effective therapies. The Company’s unique approach uses a potent, topically applied drug to inhibit TGF-β “locally”, thereby minimizing the potential risk of systemic exposure. The Company is headquartered in San Diego, California. More information can be found at www.thirona.bio.com. LFD latched onto this point in a comment at SA. seekingalpha.com/article/4430462-mannkind-new-direction-abandoning-technosphere-dpi-platform#comment-891946722LDR: Mannkind wants to convert the Thirona compound (one Thirona promotes for topical risk specifically to avoid systemic exposure) into a dry powder and dose it directly into lungs where it will immediately be put directly into a human’s systemic system and spread to every part of their body other than the eye corneas.Don't shoot the messenger I'm just relaying what I saw at SA. If someone wants rebut (correct?) LFD, the link is above. Thirona states: • We are focused on the development of novel drugs, targeting TGF-β, for the treatment of fibrotic diseases. We use a potent, topically applied drug, to inhibit TGF-β for the treatment of skin fibrosis. The drug has been specifically engineered to act locally, thereby minimizing the potential risks of systemic exposure with this target.MannKind is developing it into a dry powder formulation to be used to target fibrotic pulmonary diseases. Thirona specifically states they designed the topical formulation to act as a local agent and prevent systemic exposure (because they are a dermatological company and not focused on systemic application, they are focused on topical and locally acting agents/applications). I’m fascinated as to what you and LFD are confused about. Edited to add: I just read through LFD’s comments and his so-called article. He’s still an ass clown and a complete joke—pulling his same BS misinformation and disinformation smears. It must be absolutely killing him inside that MannKind is succeeding and about to get Tyvaso DPI approval. LOL!!
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Post by mytakeonit on Jun 11, 2021 13:54:26 GMT -5
No ... I would assume she won it on the Price is Right !
But, that's mytakeonit since I am the one that goes to service my car ... then, come home with a new car.
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Post by cretin11 on Jun 11, 2021 15:55:05 GMT -5
If your wife had that much money she could fund a clinical study to prove the superiority of afrezza, a drug that already exists. I do not ever see us doing a superiority clinical trial with Afrezza Sadly you are probably correct.
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Post by jkendra on Jun 11, 2021 17:56:52 GMT -5
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Post by kite on Jan 5, 2022 6:28:19 GMT -5
MannKind Extends Collaboration With Thirona Bio on Fibrotic Lung Diseases investors.mannkindcorp.com/news-releases/news-release-details/mannkind-extends-collaboration-thirona-bio-fibrotic-lungMannKind purchased an additional convertible note issued by Thirona Bio Nonclinical PD study of MNKD-501 planned, with results anticipated in 2Q 2022 MannKind’s CEO appointed as a member of the Thirona board of directors DANBURY, Conn., Jan. 05, 2022 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced that has extended its collaboration with Thirona Bio, Inc. (“Thirona”) with the purchase of a second convertible note issued by Thirona, and the appointment of Michael Castagna, PharmD as a member of the Thirona board of directors. Under the terms of the collaboration, which began in June 2021, the companies are evaluating the therapeutic potential of Thirona’s locally acting TGF-β inhibitor, FBM5712, for the treatment of pulmonary fibrosis. MannKind is developing MNKD-501, a dry powder inhaled formulation of FBM5712, which is advancing to a nonclinical pharmacodynamics (PD) study with key results anticipated in 2Q 2022. If initial studies are promising, MannKind can exercise certain rights to seek a full license to the compound for clinical development and commercialization for the treatment of fibrotic pulmonary diseases. FBM5712 is a novel small molecule inhibitor of ALK-5 kinase (the transforming growth factor-β (TGF-β) receptor kinase), which is also being developed by Thirona as a topical product intended to prevent and/or reduce skin fibrosis. “Our preliminary prototype powders utilized in a pharmacokinetic study in rats produced concentrations in the lungs that appear to persist long enough to suggest that the drug could perform as hoped,” said Thomas Hofmann, M.D., Ph.D., Chief Scientific Officer of MannKind Corporation. “These early positive signals warrant further evaluation and if successful, will trigger IND-enabling toxicology work for the compound.” Dr. Gordon Foulkes, Thirona Bio’s Founder and Chief Executive Officer, added, “We are pleased to progress our collaboration with further investment and guidance from the team at MannKind. We’re thrilled with the momentum since last summer and look forward to advancing a promising new formulation of FBM5712 for fibrotic lung diseases.” About MannKind Corporation MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company’s first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. Afrezza is also available by prescription in Brazil, where it is commercialized by the Company’s partner, Biomm SA. MannKind was established in 1991, and is located in Danbury, Conn., and Westlake Village, Calif. The Company also employs field sales and medical representatives across the U.S. Please visit mannkindcorp.com to learn more. About Thirona Bio Thirona Bio is focused on the development of drugs for fibrotic diseases. Target indications include scleroderma, keloid scars and certain cancers where there are no effective therapies. The company’s unique approach uses a potent, topically applied drug to inhibit TGF-β “locally”, thereby minimizing the potential risk of systemic toxicity. The company is headquartered in San Diego, California. More information can be found at www.thironabio.com.
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Post by boca1girl on Jan 5, 2022 11:34:51 GMT -5
Why don’t they state how much was spent on this convertible note and the specifics regarding the conversation? This is a private company so how would we value it except for % ownership of the company.
I guess we’ll have to wait until 1Q22 earnings are released.
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